Cath Lab Recap: TAVR & Femoral Artery Integrity; DNA Damage During EVAR
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 27, 2017 Category: Cardiology Source Type: news
This Device Has Been Around for 20 Years
It comes in different sizes and configurations now, but the Gore Excluder AAA Endoprosthesis, which seals off abdominal aneurysms from inside the aorta, hasn’t changed radically since it was introduced to the European market in 1997.
The endovascular aneurysm repair (EVAR) device has been implanted in more than 300,000 patients diagnosed with an abdominal aortic aneurysm (AAA), according to its manufacturer, W.L. Gore & Associates. Before EVAR, patients with AAA had two options: major surgery to repair the aneurysm or crossed fingers.
“The number of patients who were not candidates for surgery really drove the earl...
Source: MDDI - October 13, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Implants Design Source Type: news
Lombard touts expected 50% cost reduction in restructuring effort
Lombard Medical Technologies (NSDQ:EVAR) said today it completed a restructuring of its business after implementing a plan to focus its sales efforts on the UK, Japan and China, as well as reducing operating and manufacturing costs as it seeks to breakeven with its cash flow.
The UK-based company said that the restructuring is expected to result in a reudction of nearly $12 million in operating expenses next year when compared to last years expenditure levels, with costs reduced more than 50%.
“During 2017, we have refocused sales and marketing activities in an effort to concentrate on our highest margin markets. We...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News lombardmedical MicroPort Scientific Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 14, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. How Boston Scientific is boosting medical device value
Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life.
The...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data
Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.
The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease.
Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its exi...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials Distribution Research & Development Stents Vascular Endologix Source Type: news
Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial
Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system.
The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy differences, including more angulated aortic necks and smaller aneurysms and iliac vessels.
The analysis included 1,263 patients, with 133 female and 1,130 males. For women in the study, data indicated a 99.2% rate of successful delivery and eployment, only 0.3% l...
Source: Mass Device - September 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news
Cath Lab Recap: High-Speed OCT; EVAR; Restenosis Revasc Rising
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 1, 2017 Category: Cardiology Source Type: news
Nonoperative management rather than endovascular repair may be safe for grade II blunt traumatic aortic injuries: an eleven year retrospective analysis - Spencer SM, Safcsak K, Smith CP, Cheatham ML, Bhullar IS.
BACKGROUND: The Society of Vascular Surgery (SVS) guidelines currently suggest thoracic endovascular aortic repair (TEVAR) for grade II-IV and non-operative management (NOM) for grade I blunt traumatic aortic injury (BTAI). However, there is increasing evi... (Source: SafetyLit)
Source: SafetyLit - June 28, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Endologix touts 30-day data from study of Ovation stent graft in women
Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women.
The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to Endologix.
Previous research has shown that aneurysms grow faster in women compared to men and that female anatomy is more challenging for most traditional treatment methods.
The company’s 225-patient trial included 76 females in the treatment group and ...
Source: Mass Device - June 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Vascular Women's Health Endologix Source Type: news
Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region.
The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
“Providing a simple and straightforward procedure, the IBE preserves flow to the internal iliac arteries during EVAR. In many patients, it is imperative that iliac artery bloo...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular W.L. Gore & Associates Source Type: news
7 medtech stories we missed this week: May 19, 2017
[Image from unsplash.com]From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. XpandOrtho wins FDA 510(k) clearance
XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of th...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Body Vision Medical Exactech Inc. Lombard Medical Technologies MedTech NxThera Inc. Rivanna Medical Visionsense XpandOrtho Source Type: news
Lombard Medical CEO Hubbert, CFO Kullback step down | Personnel Moves, April 28, 2017
Lombard Medical Technologies (NSDQ:EVAR) said this month that its CEO Simon Hubbert and CFO William Kullback are stepping down from their positions, with Kurt Lemvigh stepping into the CEO role.
Hubbert served as CEO for 6 years after joining the company in 2010, and will be replaced by Lemvigh, who has held positions with multiple companies, including Cardiac Science and GE (NYSE:GE).
“Lombard represents a unique opportunity given the strength of the company’s portfolio in the over $1.5 billion market for endovascular repair products. The key to success will be our ability to leverage the work that has been don...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Accuray Inc. Becton Dickinson & Co. Boston Scientific Cardiac Sciences Corp. ConMed Corp. Fresenius GE Healthcare Lombard Medical Technologies Magnolia Medical Technologies ReWalk Robotics Senseonics Toshiba Source Type: news
Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device.
Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 Charing Cross Symposium in London this week.
“Medtronic aims to increase access to treatment for patients with aortic disease. This goal has been reinforced by our commitment to developing robust clinical programs – such as the Engage registry ̵...
Source: Mass Device - April 26, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Endoscopic / Arthroscopic Stent Grafts Vascular Medtronic Source Type: news
Benefits of Endovascular Treatment for Stroke Last at Least 2 Years (FREE)
By Kelly Young
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
The functional benefits of endovascular repair after acute stroke appear to be sustained after 2 years, according to a follow-up … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - April 5, 2017 Category: Primary Care Source Type: news
Endologix inks $170m credit facility with Deerfield
Endologix (NSDQ:ELGX) said this week it inked a credit facility worth up to $170 million with Deerfield Management.
Money in the facility will be provided through a $120 million 6-year secured term loan and a $50 million 3-year secured asset-based revolving line of credit, the Irvine, Calif.-based company said.
Under the loan facility, Deerfield will provide Endologix with $120 million or gross proceeds in funding, with Endologix agreeing to pay Deerfield a yield enhancement payment equal to 2.25% of the principal amount at the time of funding. Endologix can, at its option, repay the loan at any time.
The company said it ...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Endologix Source Type: news
